NCT05038735: Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor

Breast Cancer Type: HR+ & HER2-negative
Hormone Mutations: ER+, PR+
Other Mutations: PI3K
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 3
Drug Category: Endocrine (Hormone Therapy, Serine-Threonine Kinase Inhibitor

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: 
Additional Notes: Patient must have recurrence or progression of disease during or after combined aromatase inhibitor (AI) (i.e. letrozole, anastrozole, exemestane) & CDK4/6 inhibitor therapy; The combined AI & CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting); Patients must have a PIK3CA mutation(s) present in tumor
Exclusions: Patients who have received prior treatment with fulvestrant, any PI3K inhibitor (e.g. Piqray/alpelisib), mTOR inhibitor (e.g. Afinitor/everolimus) or AKT inhibitor (e.g. ONC201)

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